Cleared Traditional

K972203 - BABYBIRD VENTILATOR

K972203 is an FDA 510(k) clearance for BABYBIRD VENTILATOR, manufactured by Allied Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K972203 · Allied Healthcare Products, Inc. · Anesthesiology device
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Nov 1997
Decision
148d
Days
Class 2
Risk

K972203 is an FDA 510(k) clearance for the BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER,.... Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Allied Healthcare Products, Inc. (Riverside, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Allied Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K972203

510(k) Number K972203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 11, 1997
Decision Date November 06, 1997
Days to Decision 148 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 140d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K972203.
DIVAN ANESTHESIA VENTILATOR
K980208 · Draeger Medical, Inc. · Aug 1998
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
K970460 · Puritan Bennett Corp. · Apr 1998
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
K964540 · Puritan Bennett Corp. · Nov 1997
SERVO VENTILATOR 300A
K970839 · Siemens Elema AB · Oct 1997
NELLCOR PURITAN BENNETT GEMINI
K972248 · Nellcor Puritan Bennett, Inc. · Sep 1997
INFRASONICS ADULT VENTILATOR TRENDING OPTION
K964543 · Nellcor Puritan Bennett, Inc. · Feb 1997